to investigate drug-drug interaction and relative bioavailability between the fdc azelastinehcl/beclomethasone dipropionate nasal spray, & beclomethasone dipropionate nasal spray in the test vehicle, and rinoclenil® nasal spray

Conditions: Seasonal Allergic Rhinitis

Summary: an open label, randomized, three-treatment, three-period, crossover, single dose study, to investigate drug-drug interaction and relative bioavailability between the fixed dose combination azelastine hydrochloride / beclomethasone dipropionate (140/100 μg azelastine hydrochloride / beclomethasone dipropionate) nasal spray, and beclomethasone dipropionate nasal spray (100 μg beclomethasone dipropionate) in the test vehicle, and the commercially available product, rinoclenil® nasal spray (100 μg beclomethasone dipropionate), in healthy subjects under fasting conditions.


Eligibility criteria:
inclusion criteria: * the subject is caucasian \& aged between eighteen \& fifty years (18 - 50), both inclusive. * the subject is within the limits for his height \& weight as defined by the body mass index range * (18.5 - 30.0 kg/m2). * the subject is willing to undergo the necessary pre- \& post- medical examinations set by this * study. * the results of medical history, vital signs, physical examination \& conducted medical laboratory * tests are normal as determined by the clinical investigator. * the subject tested negative for hepatitis (hbsag, hcvab) viruses and human immunodeficiency * virus (hivab). * there is no evidence of psychiatric disorder, antagonistic personality and poor motivation, * emotional or intellectual problems likely to limit the validity of consent to participate in the study * or limit the ability to comply with protocol requirements. * the subject is able to understand and willing to sign the informed consent form. * for female subjects: negative pregnancy test and the woman is using two reliable contraception * methods \& should be non-lactating. * the subject has normal cardiovascular system and ecg recording. * the subject kidney and liver (ast \& alt enzymes) functions tests are within normal range. exclusion criteria: * the subject is smoker/ has positive cotinine test. * the subject has suffered an acute illness one week before dosing. * the subject has a history of or concurrent abuse of alcohol. * the subject has a history of or concurrent abuse of illicit drugs. * the subject has a history of hypersensitivity and/or contraindications to the study drug, its * excipients and any related compounds. * the subject has been hospitalized within three months before the study or during the study. * the subject is vegetarian. * the subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days * before dosing and until 23 hours after dosing in all study periods. * the subject has taken a prescription medication within two weeks or even an over the counter * product (otc) within one week before dosing in each study period and any time during the study, * unless otherwise judged acceptable by the clinical investigator. * the subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before * first dosing and any time during the study. * the subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and * bioequivalence studies) within the last 80 days prior to the present study. * the subject has donated blood within 80 days before first dosing. * the subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, * hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or * psychiatric diseases. * the subject has consumed drugs that may affect pharmacological or pharmacokinetic properties * (ritonavir, cobicistat \& cns depressants) two weeks before dosing, during the study and two * weeks after dosing. * the subject has recent nose surgery or a history of chronic sinusitis, recent urti and nasal septum * deviation that may affect nasal mucosa integrity.